Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
Primary Purpose
Stress Disorders, Post-Traumatic, Depressive Symptoms, Hydrocortisone
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Mindfulness-based Stress Reduction
Health Promotion Wellness Classes
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Trauma
Eligibility Criteria
Inclusion Criteria:
- self-reported homeless women
- age 18+
- willing to provide informed consent
- lifetime exposure to at least one DSM-V qualifying trauma
- likely subthreshold or threshold PTSD, as measured by the PCL-5.
Note: A homeless person is defined as anyone who spent the previous night in a public or private shelter, or on the street.
Exclusion Criteria:
- not speaking English
- judged to be cognitively impaired; as indicated by score >9 on the Short-Blessed Screener (SBS).
Sites / Locations
- North County Serenity House
- Prototypes Women's Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified Mindfulness-based Stress Reduction
Health Promotion Attention Control
Arm Description
Outcomes
Primary Outcome Measures
Post-traumatic Stress Symptoms
Clinically significant improvement in Posttraumatic Stress Symptoms - PTS (i.e., decrease in symptoms), as measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). The PCL-5 is a 20-item scale (range 0-80), with rating scale descriptions: 0 "Not at all," 1 "A little bit," 2 "Moderately," 3 "Quite a bit," and 4 "Extremely." Higher scores indicate more PTSD symptoms.
Secondary Outcome Measures
Depression
Change in depressive symptoms from baseline to follow-ups (i.e., decrease in symptoms), using the Patient Reported Outcomes Measurement Information System (PROMIS) measure for depression. The PROMIS asks 9-items (range 9-45) with response options: 1 "never", 2 "rarely", 3 "sometimes", 4 "often", and 5 "always". Higher scores indicate more symptoms of depression.
Substance Use (self-report)
Change in substance use from baseline to follow-ups using the Texas Christian University Screen
Substance Use (objective)
Change in substance use from baseline to follow-up using 5-panel FDA-approved urine test cup
Cortisol reactivity
Change in cortisol reactivity using script driven imagery from baseline to follow-up using standard manufacturer protocols (from Salimetrics).
C-Reactive Protein (CRP)
Change in CRP, measured via saliva using the Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay.
Full Information
NCT ID
NCT04605198
First Posted
October 21, 2020
Last Updated
September 19, 2022
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04605198
Brief Title
Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
Official Title
Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Posttraumatic stress disorder (PTSD) is a major public health concern that disproportionately effects minorities and those with low-socioeconomic status, such as homeless women, creating a critical health disparity. PTSD has been linked with dysregulated hypothalamic-pituitary-adrenal (HPA) functioning and increased inflammation, which can lead to long-term physical-health problems and PTSD-symptom maintenance, exacerbating disparities. Mindfulness-based interventions, including Mindfulness-based Stress Reduction (MBSR), have shown promise as a complementary tool for addressing PTSD in veterans and with low-income, minority populations, but homeless women have not been examined adequately. MBSR may improve PTSD symptomatology and help modulate the dysregulated stress response common in individuals with PTSD, improving physical and mental health concurrently. This project is an open-label, parallel, modified-cross over clinical trial of a modified-MBSR intervention to reduce PTSD symptoms in homeless women and to explore physiological correlates of treatment-response.
Hypotheses:
Participation in an MBSR-based intervention will be associated with clinically significant reduction in PTSD (primary outcome), lower depression symptoms and greater drug and alcohol abstinence (secondary outcomes) compared to participation in an attention control.
Compared to an attention control, participants in an MBSR-based intervention group will demonstrate improvements in cortisol reactivity and lower inflammation.
At baseline, women will complete psychosocial assessments (e.g., depression, substance use, trauma history) and participate in a brief stress task, providing salivary samples before and after the task (which will be assayed for cortisol and C-reactive protein, a marker of inflammation). Women will then participate in 1) a 9-session MBSR-based program that was modified based on an initial qualitative component that involved a Community Advisory Board and focus groups with women from the community (N=4 focus groups; 28 women total) or 2) a nine-session health-promotion course (i.e., attention-control condition). Follow-up assessments that include psychosocial and biological data will occur immediately after final intervention session and again 6-months later. Clinically-meaningful improvements in PTSD (primary outcome) and secondary outcomes (e.g., depression, substance use, inflammation, cortisol reactivity) will be examined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Depressive Symptoms, Hydrocortisone, Substance Use
Keywords
PTSD, Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be recruited from two sites. To avoid contamination between subjects living at the sites, using a quasi-randomized method, all participants at each site will receive the same treatment per cohort. Sites will alternate between the assignment of treatment (modified-MBSR) or control (health promotion class) in sequential cohorts to account for between site differences.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Mindfulness-based Stress Reduction
Arm Type
Experimental
Arm Title
Health Promotion Attention Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Modified Mindfulness-based Stress Reduction
Other Intervention Name(s)
modified MBSR
Intervention Description
Participants will be trained in mindfulness meditation and the applicability of mindfulness practices to daily life. During MBSR programming, teachers will lecture about key topics in mindfulness and lead class discussions. Participants are given homework assignments, such as listening to guided meditations. Participants are given opportunities to ask the instructor questions and to share their experiences with each other. Each session focuses on a different key topic. Topics are: Session 1: Introduction; Session 2: Understanding Perceptions; Session 3: Hatha Yoga, Sitting Meditation, Walking Meditation; Session 4: Concentration & Awareness; Session 5: Unhealthy Patterns &Getting Unstuck; Session 6: Transformational Coping Strategies; Session 7: Mini-retreat; Session 8: Maintaining Discipline & Flexibility; Session 9: Course Review.
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion Wellness Classes
Intervention Description
Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation.
Primary Outcome Measure Information:
Title
Post-traumatic Stress Symptoms
Description
Clinically significant improvement in Posttraumatic Stress Symptoms - PTS (i.e., decrease in symptoms), as measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). The PCL-5 is a 20-item scale (range 0-80), with rating scale descriptions: 0 "Not at all," 1 "A little bit," 2 "Moderately," 3 "Quite a bit," and 4 "Extremely." Higher scores indicate more PTSD symptoms.
Time Frame
Immediately post-intervention & 6-month follow-up
Secondary Outcome Measure Information:
Title
Depression
Description
Change in depressive symptoms from baseline to follow-ups (i.e., decrease in symptoms), using the Patient Reported Outcomes Measurement Information System (PROMIS) measure for depression. The PROMIS asks 9-items (range 9-45) with response options: 1 "never", 2 "rarely", 3 "sometimes", 4 "often", and 5 "always". Higher scores indicate more symptoms of depression.
Time Frame
Immediately post-intervention & 6-month follow-up
Title
Substance Use (self-report)
Description
Change in substance use from baseline to follow-ups using the Texas Christian University Screen
Time Frame
Immediately post-intervention & 6-month follow-up
Title
Substance Use (objective)
Description
Change in substance use from baseline to follow-up using 5-panel FDA-approved urine test cup
Time Frame
Immediately post-intervention & 6-month follow-up
Title
Cortisol reactivity
Description
Change in cortisol reactivity using script driven imagery from baseline to follow-up using standard manufacturer protocols (from Salimetrics).
Time Frame
Immediately post-intervention & 6-month follow-up
Title
C-Reactive Protein (CRP)
Description
Change in CRP, measured via saliva using the Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay.
Time Frame
Immediately post-intervention & 6-month follow-up
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women are eligible for the study.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
self-reported homeless women
age 18+
willing to provide informed consent
lifetime exposure to at least one DSM-V qualifying trauma
likely subthreshold or threshold PTSD, as measured by the PCL-5.
Note: A homeless person is defined as anyone who spent the previous night in a public or private shelter, or on the street.
Exclusion Criteria:
not speaking English
judged to be cognitively impaired; as indicated by score >9 on the Short-Blessed Screener (SBS).
Facility Information:
Facility Name
North County Serenity House
City
Escondido
State/Province
California
ZIP/Postal Code
92026
Country
United States
Facility Name
Prototypes Women's Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
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